Non Hodgkin Lymphoma Clinical Trial

A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer

Summary

The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age < 18 years for Part A and Part B
Age up to 30 years for Part B Cohorts B2, B3 and B4
Must have received standard of care therapy and there must be no potentially curative treatment available
Histologically confirmed with malignant neoplasms that are refractory, relapsed, or curative treatments are lacking
Must have measurable or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for solid tumors, Response Assessment in Neuro-Oncology (RANO) or Response Assessment in Pediatric Neuro-Oncology (RAPNO) for central nervous system tumors, International Pediatric Non-Hodgkin Lymphoma Response Criteria for non-Hodgkin lymphoma (NHL), revised International Neuroblastoma Response Criteria (INRC) for neuroblastoma, modified National Comprehensive Cancer Network (NCCN) Criteria for acute lymphoblastic leukemia, and modified Cheson et al International Working Group criteria for acute myeloid leukemia
Lansky play score for age ≤ 16 years or Karnofsky performance score for age > 16 years assessed within 2 weeks of enrollment must be ≥ 60

Exclusion Criteria:

Osteosarcoma, T-cell/Natural Killer (NK) cell leukemia/lymphoma, and Hodgkin's lymphoma
Need for > 2 antihypertensive medications for management of hypertension (including diuretics)
Known cardiovascular history, including unstable or deteriorating cardiac disease, within the previous 12 months prior to screening
Inadequately treated adrenal insufficiency
Active, known, or suspected autoimmune disease
Active infection requiring systemic therapy within 14 days prior to first dose
Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
Prior allogeneic stem cell transplant
Previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection either suspected or confirmed within 4 weeks prior to screening

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

15

Study ID:

NCT04730349

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 18 Locations for this study

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Local Institution - 0029
Little Rock Arkansas, 72202, United States
Local Institution - 0011
Saint Louis Missouri, 63110, United States
Local Institution - 0001
Randwick New South Wales, 2031, Australia
Local Institution
South Brisbane Queensland, 4101, Australia
Local Institution - 0002
Parkville Victoria, 3052, Australia
Local Institution - 0003
Perth Western Australia, 6009, Australia
Local Institution - 0013
Villejuif Val-de-Marne, 94805, France
Local Institution - 0014
Lyon , 69373, France
Local Institution - 0016
Marseille , 13385, France
Local Institution - 0015
Paris , 75005, France
Local Institution - 0038
Hamburg , 20246, Germany
Local Institution - 0039
Tuebingen , 72076, Germany
Local Institution - 0037
Wuerzburg , 97080, Germany
Local Institution - 0027
Milan , 20133, Italy
Local Institution - 0008
Barcelona , 08035, Spain
Local Institution - 0009
Madrid , 28009, Spain
Local Institution - 0059
Sevilla , 41013, Spain
Local Institution - 0028
València , 46026, Spain

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

15

Study ID:

NCT04730349

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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